Brijjit® for Mastectomy

Overseen By Thomas Calahan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Accutane, Glucocorticoids, Immunosuppressants

Disqualifiers: Allergies, Scarring, Autoimmune, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Brijjit®, a new method for closing surgical wounds, in individuals undergoing gender-affirming mastectomies. Researchers aim to determine if Brijjit® improves scar appearance and reduces wound complications compared to traditional stitches. Individuals who self-identify as transgender or gender expansive and plan to have a double incision mastectomy at NYU Langone Health may qualify to participate. Participants must manage their wound care and attend follow-up visits for a year post-surgery. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have used certain medications like Accutane, systemic glucocorticoids, or local immunosuppressants in the past year, you may not be eligible to participate.

What prior data suggests that Brijjit® is safe for wound closure in gender affirming mastectomies?

Research shows that Brijjit® FMTB (Force Modulating Tissue Bridges) generally provides a safe method for closing wounds. Studies have found it to be well-tolerated, with only a few instances of the device not performing as expected. This indicates that most users experience no issues. Importantly, Brijjit® is non-invasive, meaning it doesn't require cutting into the skin, often making it safer and easier to use than treatments involving incisions.

Prospective trial participants should discuss any concerns with their doctor, who can provide more details on what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brijjit® for wound closure in gender-affirming mastectomies because it offers a novel approach compared to traditional sutures. Unlike sutures that involve stitching the skin together, Brijjit® uses a flexible microtissue bridge (FMTB) to close the wound, which could potentially reduce scarring and improve healing. This innovative method aims to provide a more aesthetic result, which is especially important in gender-affirming surgeries where appearance and minimizing visible scarring are crucial. By offering a different mechanism for wound closure, Brijjit® could enhance patient satisfaction and recovery times.

What evidence suggests that Brijjit® is effective for wound closure in gender affirming mastectomies?

Research shows that Brijjit® Force Modulating Tissue Bridges (FMTB) can significantly improve wound closure compared to regular stitches. One study found that FMTB reduced the risk of complications by 89% compared to traditional methods, resulting in fewer issues like infections or poor healing. In this trial, participants will have one chest closed using Brijjit® FMTB, while the other will use traditional suture-based methods as an internal control. Brijjit® devices reduce skin tension, promoting better wound healing and less noticeable scars. Early data from other surgeries using Brijjit® showed no infections at the surgery site, suggesting strong potential for improved outcomes in gender-affirming mastectomies. ^{1 3 6 7 8}

Who Is on the Research Team?

Rachel Bluebond-Langner

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

Willingness to return for scheduled follow-up visits through 1 year post-operatively

English Speaking

Patient self-identifies as Transgender or Gender Expansive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo bilateral double incision gender affirming mastectomies with one side receiving Brijjit® FMTB and the other serving as a control

1 day

1 visit (in-person)

Follow-up

Participants are monitored for scar appearance and wound complications using various assessment tools

12 months

Visits at baseline, week 2, week 4, week 6, week 8, 3-month, 6-month, and 12-month post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Brijjit®

How Is the Trial Designed?

Group I: Right chest with Brijjit® FMTB Experimental Treatment 1 Intervention

Patients will be assigned to have their right chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

Group II: Left chest with Brijjit® FMTB Experimental Treatment 1 Intervention

Patients will be assigned to have their left chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/16/NCT05028816/Prot_SAP_000.pdf

Brijjit Protocol Version 6: May 22, 2024 1 of 17 TITLE Prior pre-clinical studies show that the devices are more effective than suture at off-loading skin tension and that they can provide superior ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10902893/

Tension Reduction With Force Modulating Tissue Bridges ... This is a large effect; FMTB demonstrates an 89% relative risk reduction vs conventional closure. Only 8 patients need to be treated with FMTB to prevent a ...

3. brijmedical.com brijmedical.com/wp-content/uploads/2024/02/2018ASJKazmerEavesForceModulatingTissueBridges.pdf

Force Modulating Tissue Bridges for Reduction of Tension ... FMTB performance of wound closure relative to sutures was performed through image analysis. The images from the lab session were first rotated and cropped ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07147166

Evaluating the Efficacy of Force Modulating Tissue Bridge ... We hypothesize that applying FMTBs to surgical incisions will improve scar outcomes by limiting pro-fibrotic signaling and promoting optimal wound healing.

5. brijmedical.com brijmedical.com/clinical-evidence/

Clinical Evidence PRELIMINARY DATA: This case study highlights the clinical impact of Brijjit devices in total joint procedures, demonstrating zero surgical site infections, ...

6. brijmedical.com brijmedical.com/wp-content/uploads/2024/02/Tension-Reduction-With-Force-Modulating-Tissue-Bridges-Reduces-Wounds-in-Breast-Surgery-Holly-C.-Wall-MD-FACS-1-1.pdf

Tension Reduction With Force Modulating Tissue Bridges ... FMTB use is safe, with limited premature device failure. The implications of a wound are amplified in the setting of an underlying prosthetic implant. FMTB ...

7. brijmedical.com brijmedical.com/wp-content/uploads/2023/11/Kenkel-et-al-Brijjit-RCT-Decreases-Wounds-and-Scars.pdf

Early Scar Analysis From a Randomiz Objectives: The study objective was to assess the efficacy of the force modulating tissue bridge (FMTB) (“Brijjit”, Brijjit. Medical Inc., Atlanta, GA) in ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05028816

Force Modulating Tissue Bridges for Closure of Vertical ... Also called a data safety and monitoring board, or DSMB. ... Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar ...